U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Medical Image Storage Device - Product Code LLZ
원인
Loss of patient data can occur under certain circumstances due to misconfiguration of dicomstore configured with agfa's medical image storage devices - media purge daemon (mpd) and cardiovascular purge service (cps).
조치
On 8/9/2012 AGFA Healthcare issued an "URGENT FIELD SAFETY NOTICE" letter to consignees. This letter describes the problem and mitigation. Acknowledgment, via FAX-Back or email, that the information was received and understood was also required from the consignees